An Investigational Device Exemption (IDE) allows significant risk device to be used in a clinical study. Clinical studies are conducted to support a premarket approval (PMA) or to evaluate certain modifications or new intended uses of legally marketed devices. All clinical investigations of significant risk devices must have an approved IDE or meet exemption criteria.
A clinical investigator may wish to submit an IDE to FDA and act as the sponsor of significant risk device study. The sponsor-investigator is responsible for obtaining approval from both FDA and Institutional Review Board (IRB) prior to enrolling patients at the study site.
- Device Category and IDE Exemption Criteria
- Pre-submission Program and Meetings with the FDA
- FDA Pre-determination Program for Study Risk Determinations
- Pre-determination Request Cover Letter Template